A Renal Impairment Study for PF-04965842

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

This study is a phase 1 non-randomized, open-label, single-dose, parallel-group study of PF 04965842 in subjects with severe renal impairment and subjects without renal impairment (Part 1) and in subjects with moderate renal impairment (Part 2).

Key facts

Study ID

NCT03660241

Run by

Pfizer

People needed

23

Starts

2018-10-05

Expected to finish

2019-11-05

Last updated by the study team

2022-03-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Breath alcohol test at Screening and Day -1 must be negative.
• Body mass index (BMI) of ≥ 17.5 to ≤ 40.0 kg/m2; and a total body weight >50 kg (110 lb).
• Additional inclusion criteria for subjects with renal impairment:
• Meet the following eGFR criteria during the screening period based on the MDRD equation:
• Severe renal impairment: eGFR <30 mL/min, but not requiring hemodialysis.
• Moderate renal impairment (Part 2 only): eGFR ≥30 mL/min and <60 mL/min.
• Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included).
• Stable concomitant drug regimen.

You may not qualify if…

• Renal transplant recipients.
• Urinary incontinence without catheterization.
• Subjects with clinically significant infections within the past 3 months (for example, those requiring hospitalization, or as judged by the Investigator), evidence of any infection (including influenza) within the past 7 days prior to baseline, history of disseminated herpes simplex infection or recurrent or disseminated herpes zoster.
• Subjects with a malignancy or with a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
• History of or current positive results for human immunodeficiency virus, Hepatitis B, Hepatitis C.
• Additional exclusion criteria for subjects with renal impairment:
• Subjects requiring hemodialysis and peritoneal dialysis.
• Screening BP ≥ 180 mm Hg (systolic) or ≥ 110 mm Hg (diastolic).
• Screening supine 12-lead ECG demonstrating QTcF >470 msec or a QRS interval >120 msec.

Where it is running

• University of Miami Division of Clinical Pharmacology — Miami, Florida, United States
• University of Miami, Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• Brussels Clinical Research Unit — Brussels, Be-bru, Belgium

Full record on ClinicalTrials.gov

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